Following July's disappointing preliminary results in its Phase II trialof Bradycor for sepsis, Cortech Inc. said late last week a subsequentanalysis of the data has revealed more encouraging findings in asubgroup of patients infected with gram-negative organisms.
"We're very encouraged," said Christi Foster, Cortech's director ofcommunications. "This is good data for the drug." But she added thatthe company would need more financial resources and a corporatepartner to conduct additional sepsis studies with Bradycor, which is abradykinin antagonist. Sepsis is a bacterial blood infection that killsan estimated 70,000 people a year.
The Phase II trial involved 504 patients receiving a three-dayinfusion of placebo or Bradycor in one of three doses. Data from thefull study showed no statistically significant reduction in 28-daymortality when Bradycor-treated patients were compared with thosewho received a placebo.
However, in the subsequent analysis of 112 patients suffering fromsepsis caused by gram-negative organisms, investigators reported astatistically significant improvement in risk-adjusted survival over 28days. The most dramatic reduction in mortality occurred in the highdose group of 27 patients with a 50.2 percent predicted risk of dying.After treatment with Bradycor, the group experienced a 22.2 percentmortality rate compared with 50 percent for patients treated with aplacebo.
The data from the 112-patient subgroup also showed an overall 19percent survival rate at 28 days for Bradycor-treated participants, butthat finding was not significant when compared with placebo-controlled patients.
Foster said no decisions will be made on further development ofBradycor for sepsis until analyses of data from the three-day Phase IIstudy and a second Phase II trial are complete. In the latter trial,patients received Bradycor for seven days and those findings shouldbe released in early 1995.
Timothy Rodell, executive vice president of operations and productdevelopment, said Cortech views the positive subgroup data "withguarded optimism," recognizing "that subgroup analyses must beinterpreted cautiously."
In a prepared statement, Rodell said, "The record of repeated failureson the part of biotech companies to demonstrate drug efficacy insepsis is well known, and the company is very conscious of theclinical difficulties inherent in pursuing this indication."
In July, Cortech's stock dropped 60 percent to $2.25 followingannouncement of the data from the preliminary analysis of the three-day Phase II trial.
In addition to patients with gram-negative infections, two othersubgroups included in the second analysis were patients with gram-positive infections and those with a 25 percent or greater predictedrisk of dying. No statistically significant improvement in survivalrate was found in either group.
Bradycor also is being tested in trials involving patients withmultiple trauma, burns and hantavirus. Last month, results from aPhase II study involving 20 head trauma patients with brain edemarevealed a statistically significant reduction in swelling amongparticipants treated with Bradycor.
Cortech's stock (NASDAQ:CRTQ) Friday closed at $3.12, down 12cents.
Editor's note: The Friday edition of BioWorld Today included anarticle about Cortech's Phase II trial results of Bradycor which werepreviously reported. Today's article includes the latest news. n
-- Charles Craig
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